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"Skripsi ini membahas pelaksanaan prosedur tetap pengelolaan limbah cair RSUT Tangerang Tahun 2009 dilihat dari sisi kepatuhan petugas Instalasi Pengolahan Air Limbah. Penelitian ini merupakan penelitian kualitatif yang bersifat deskriptif analitik. Hasil penelitian menunjukkan bahwa kegiatan pengelolaan limbah cair Rumah Sakit Umum Tangerang telah berjalan dengan baik namun belum sepenuhnya maksimal. Oleh karena itu diperlukan upaya untuk meningkatkan kinerja dan menjaga konsistensi perilaku kepatuhan petugasInstalasi Pengolahan Air Limbah yaitu dengan mengintensifkan koordinasi antar petugas Instalasi Pengolahan Air Limbah saat, mengadakan diskusi antar petugas Instalasi Pengolahan Air Limbah, evaluasi di awal dan akhir pelaksanaan kegiatan pengelolaan limbah cair."

"Halal dan haram menjadi titik kritis dalam pola konsumsi masyarakat, khusunya di Indonesia yang mayoritas masyarakatnya memeluk agama Islam. Penyelenggaraan jaminan produk halal dalam proses pembuatan obat telah diatur oleh Peraturan Pemerintah Republik Indonesia Nomor 39 Tahun 2021 tentang penyelenggaraan bidang jaminan produk halal pasal 141 yang menyatakan bahwa industri farmasi berkewajiban melaksanakan penahapan sertifikat halal pada produknya. Kelancaran setiap proses pembuatan obat di industri farmasi dipengaruhi oleh beberapa faktor, salah satunya adalah prosedur kerja. Dalam mencapai kinerja yang profesional, efektif, dan efisien, maka diperlukan suatu prosedur standar yang menjadi pedoman pada setiap pelaksanaan kegiatan dalam sebuah industri farmasi. Prosedur dalam sistem kerja dikenal sebagai standar operasional prosedur (SOP) atau prosedur tetap (Protap). Salah satu protap yang diterapkan industri farmasi dalam upaya pemastian dan pengawasan mutu produk obat yaitu mengenai cara penanganan kebersihan peralatan maupun mesin, khususnya ketika terkena najis. Protap dibuat untuk merinci tiap tahap pembersihan dan sanitasi peralatan maupun mesin yang digunakan selama proses produksi guna meminimalisir terjadinya kontaminasi pada masing-masing peralatan yang nantinya akan disimpan dalam keadaan bersih dan kering. Melalui tugas khusus ini, telah disusun protap umum cara penanganan peralatan atau mesin sesuai dengan kriteria SJH, cara pembersihan dan sanitasi peralatan sesuai persyaratan yang terdapat pada CPOB, serta Prosedur Tetap Umum Cara Pembuatan dan Penomoran

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Halal and haram are a critical point in people's consumption patterns, especially in Indonesia where the majority of people embrace Islam. Implementation of halal product guarantees in the drug manufacturing process has been regulated by Government Regulation of the Republic of Indonesia Number 39 of 2021 concerning the implementation of halal product guarantees article 141 which states that the pharmaceutical industry is obliged to carry out halal certificate stages for its products. The smooth running of every drug manufacturing process in the pharmaceutical industry is influenced by several factors, one of which is work procedures. In achieving professional, effective and efficient performance, a standard procedure is needed to guide every activity in the pharmaceutical industry. Procedures in the work system are known as standard operating procedures (SOP) or regular procedures (Protap). One of the procedures applied by the pharmaceutical industry in an effort to ensure and control the quality of medicinal products is regarding how to handle the cleanliness of equipment and machines, especially when exposed to feces. Protaps are made to detail each stage of cleaning and sanitizing equipment and machines used during the production process in order to minimize the occurrence of contamination on each equipment which will later be stored in a clean and dry condition. Through this special assignment, a general procedure for handling equipment or machines has been prepared in accordance with the SJH criteria, a method for cleaning and sanitizing equipment according to the requirements contained in GMP, as well as the General Procedures for Making and Numbering the Standard Procedures applicable at PT. Guardian Pharmatama."

"Waktu tunggu didefinisikan sebagai jangka waktu dimana bahan (bahan awal yang dikeluarkan, produk antara dan dalam jumlah besar menunggu pengemasan akhir) dapat ditahan pada kondisi tertentu dan akan tetap berada dalam spesifikasi yang telah ditentukan. Studi waktu tunggu menetapkan batas waktu untuk menyimpan bahan pada berbagai tahap produksi. Hal ini memastikan bahwa kualitas produk tidak memberikan hasil di luar kriteria penerimaan selama waktu tunggu. PT Guardian Pharmatama sebagai industri farmasi harus memastikan bahwa produk yang mereka hasilkan aman, efektif, dan berkualitas sesuai dengan penggunaan yang dimaksudkan dengan cara membuat prosedur tetap, protokol, serta laporan studi waktu tunggu (bulk holding time study) bersama dengan Departemen Quality Assurance divisi Quality Management System agar pelaksanaan studi dapat terlaksana dengan baik. Tahapan pelaksanaannya meliputi studi literatur terkait, menyusun prosedur tetap, sirkulasi persetujuan prosedur tetap ke semua penanggung jawab terkait, menyusun protokol, sirkulasi persetujuan protokol ke semua penanggung jawab terkait, melakukan persiapan sampel dan melaksanakan studi waktu tunggu (bulk holding time study), melakukan pemeriksaan hasil studi dan membuat laporan, serta sirkulasi persetujuan laporan ke semua penanggung jawab terkait. Berdasarkan hasil studi waktu tunggu (bulk holding time study) yang dilakukan, semua parameter pengujian bahan awal setelah ditimbang sebelum proses pencampuran, larutan penyalut, tablet/ kaplet ke tahap coatinng, serta tablet salut selaput/ kaplet salut selaput pada Produk Obat Tradisional/ Suplemen Kesehatan memenuhi syarat kualitas selama waktu penyimpanannya.

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Bulk Holding Time is defined as the period during which materials (dispensed raw materials, intermediates, and bulk products awaiting final packaging) can be held under specified conditions and remain within predefined specifications. Bulk Holding Time studies establish the time limits for holding materials at various production stages. This ensures that the product quality does not yield results outside the acceptance criteria during the bulk holding time. PT Guardian Pharmatama, as a pharmaceutical industry, must ensure that the products they produce are safe, effective, and of quality according to their intended use by developing standard procedures, protocols, and bulk holding time study reports in collaboration with the Quality Assurance Department of the Quality Management System division to ensure proper implementation of the study. The implementation stages include relevant literature studies, drafting standard procedures, circulating the approval of standard procedures to all relevant responsible parties, drafting protocols, circulating the approval of protocols to all relevant responsible parties, preparing samples and conducting the bulk holding time study, examining study results, drafting reports, and circulating the approval of reports to all relevant responsible parties. Based on the results of the bulk holding time study conducted, all test parameters for raw materials after weighing before the mixing process, coating solutions, tablets/caplets to the coating stage, as well as film-coated tablets/film-coated caplets in Traditional Medicine/Health Supplement Products meet the quality requirements during their storage time."

"One of the Indonesian health problems is under 5-year child`s mortality still high. This highly mortality is caused by Pneumonia (10, 6/1000 children. The effort to decrease this problem is by enchanting Acute Respiratory Tract Infection (ARTI) service standard, which the health workers compliance to the Standard Operating Procedure (SOP) can be performed. The strategy to overcome this problem is by approaching the Quality Assurance. The objective of this study is to get the description of staff level compliance to the standard operating procedure of the ARTI service at the Health centers. In the otherhand also to find the correlation of characteristic factors and the dominant factors to health workers compliance. This study was carried out on April until May 2001 at 7 Health Centers, where the Quality Assurance had already applied. The objects of this study were 35 health workers who conduct the ARTI health serviceman. This study was cross sectional, analyzing univariate, bivariate and also multivariate were used to find the distribution, correlation and the major factors.The result showed that the proportion of the health workers compliance at those 7 Health Centers are still low, especially for the counseling activity. The bivariate analysis showed that there was a predominant factor, as knowledge, training and supervision significantly correlated to the compliance of the Health workers. Multivariate analysis showed us that the most dominant factor is Health training concerning to the ARTI. Supporting this effort, staff training is needed to improve the quality of the health services."

"CPOB atau Cara Pembuatan Obat yang Baik merupakan cara pembuatan obat dan/atau bahan obat yang bertujuan untuk memastikan agar mutu obat dan/atau bahan obat yang dihasilkan sesuai dengan persyaratan dan tujuan penggunaan. okumentasi yang baik menjadi bagian yang esensial dari sistem pemastian mutu dan merupakan kunci untuk pemenuhan persyaratan CPOB. Dokumen berupa prosedur atau disebut juga prosedur tetap merupakan dokumen yang memberikan petunjuk cara pelaksanaan suatu kegiatan tertentu. Prosedur tetap sendiri juga mungkin saja untuk mengalami perubahan, hal ini berkaitan dengan upaya untuk mempertahankan atau meningkatkan mutu obat (BPOM, 2018). Tugas ini bertujuan untuk memahami metode tinjau ulang dan revisi prosedur tetap di bagian produksi steril PT. Mahakam Beta Farma, serta memahami metode tinjau ulang dan revisi prosedur tetap di bagian produksi steril PT. Mahakam Beta Farma. Metode yang digunakan adalah studi literatur terhadap prosedur tetap yang masih berlaku dan hasil kualifikasi QA. Hasil yang dapat disimpulakn adalah dilakukan tinjau ulang terhadap prosedur tetap yang masih berlaku atau terhadap hasil kualifikasi QA, selanjutnya dilakukan cek kesesuaian dengan kondisi saat ini dengan melakukan wawancara terhadap supervisor atau group leader terkait.

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GMP or Good Drug Manufacturing Practice is a method of manufacturing drugs and/or drug ingredients with the aim of ensuring that the quality of drugs and/or medicinal ingredients produced is in accordance with the requirements and intended use. Good documentation is an essential part of the quality assurance system and is the key to meeting GMP requirements. Documents in the form of procedures or also called permanent procedures are documents that provide instructions on how to carry out certain activities. The fixed procedure itself is also possible to change, this is related to efforts to maintain or improve drug quality (BPOM, 2018). This assignment aims to understand the method of reviewing and revising the fixed procedures in the sterile production section of PT. Mahakam Beta Farma, as well as understanding the method of review and revision of fixed procedures in the sterile production section of PT. Mahakam Beta Farma. The method used is a literature study of the procedures that are still valid and the results of QA qualifications. The results that can be concluded are that a review of the fixed procedures that are still in effective period or based on the results of the QA, then a check is carried out for conformity with current conditions by conducting interviews with related supervisors or group leaders."

"Obat merupakan produk dengan sifat dinamis sehingga kualitas dari obat tersebut haruslah terus dijaga, salah satunya dengan cara kontrol mutu. Kontrol mutu dapat dilakukan dimulai dari pengujian bahan awal dan bahan kemas untuk memastikan spesifikasi dan identitas sesuai. Prosesur tetap terkait dengan pengambilan sampel serta disposisi bahan awal dan bahan kemas penting untuk dibuat dan diterapkan agar seluruh proses tersebut berlangsung secara teratur, terdokumentasi dengan baik, dan sesuai dengan ilmu serta regulasi terbaru. Maka dari itu, perlu dilakukan secara berkala penilaian kesenjangan prosedur tetap. Metode yang digunakan yaitu studi literatur mengenai regulasi terbaru yaitu WHO Annex 4, kemudian dilakukan pengamatan serta analisis kesenjangan antara prosedur tetap dan WHO Annex dengan memberikan nilai kesesuaian. Selanjutnya dibentuk solusi untuk permasalahan yang terjadi. Berdasarkan penilaian kesenjangan yang telah dilakukan, prosedur tetap telah memenuhi setidaknya 8 poin, hanya memenuhi sebagian dari 6 poin, dan tidak memenuhi sebanyak 2 poin dari total 16 poin yang tertera pada WHO Annex 4. Persentase pemenuhan prosedur tetap disposisi bahan awal dan bahan kemas yaitu sebesar 68,75%. Beberapa daftar poin yang belum terpenuhi atau hanya sebagian terpenuhi meliputi belum lengkapnya detail pernyataan fasilitas pengambilan sampel, tanggung jawab untuk pengmabilan sampel, hingga metode serta pola pengambilan sampel di prosedur operasional. Namun, pada kondisi aktual, poin yang belum terpenuhi tetap dilakukan sesuai dengan regulasi yang berlaku.

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Drugs are products with dynamic properties so that the quality of these drugs must be maintained, one of which is by means of quality control. Quality control can be carried out starting from testing of starting materials and packaging materials to ensure proper specifications and identity. It is important to have established and implemented standard operation procedure related to the sampling and disposition of starting materials and packaging materials to ensure that these processes are appropriate, well-documented and in accordance with the latest science and regulations. Therefore, it is necessary to periodically assess the fixed procedure gap. The method used is a literature study regarding the latest regulations, namely WHO Annex 4, then do an observation and analysis regarding the gaps between the standard procedures and the WHO Annex by giving values for each statement. Then a solution is formed for the problems that occur. Based on the gap assessment that has been carried out, the standard operation procedures have fulfilled at least 8 points, only fulfilled a portion of the 6 points, and did not fulfil as many as 2 points out of the total 16 points listed in WHO Annex 4. The percentage of compliance with WHO Annex 4 is 68.75%. Some of the list of points that have not been fulfilled or only partially fulfilled include incomplete detailed statements of sampling facilities, responsibilities for sampling, to methods and patterns of sampling in operational procedures. However, in actual conditions, points that have not been fulfilled are still carried out in accordance with applicable regulations."

"Tesis ini merupakan penelitian yang bersifat deskriptif analitik yang akan menganalisis kesenjangan (gap) yang ada antara Standar yang berlaku dengan implementasi di lapangan mengenai sistem penanggulangan tumpahan minyak pada kegiatan hulu migas. Hasil penelitian ini memberikan gambaran tentang penyebab terjadi tumpahan minyak pada kegiatan hulu migas dan cara penanggulangannya. Data yang digunakan pada penelitian ini adalah data sekunder yang didapatkan dari Lembaga X. Adapun data tersebut mencakup organisasi emergency response dan prosedur tetap (PROTAP) Peralatan Tumpahan Minyak skala tier 1 yang terkini serta peralatan yang handal dan siap pakai skala tier 1. Selain itu dihasilkan rekomendasi-rekomendasi terkait sistem penanggulangan tumpahan minyak pada kegiatan hulu migas.

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This thesis is a descriptive analytic study which will analyze the gaps that exists between the standards that apply to the implementation on the ground regarding the oil spill response system in the upstream oil and gas activities. The study provides an overview of the causes of an oil spill in the upstream oil and gas activities and ways to overcome them. The data used in this research is secondary data obtained from the Institute X. The data include emergency response organization and, procedures and equipment (PROTAP) Oil Spill Equipment tier scale of 1 to date and reliable equipment and ready-made scale of tier 1. Other than that produced recommendations for oil spill response systems related to the upstream oil and gas activities."